Specialty CompoundingMike, a native Texan, had a calcium gluconate IV placed in his arm to treat gallstones. About three days later, his stomach swelled and he developed a redness in his groin region. Physicians diagnosed Mike with a bacterial blood infection and prescribed him antibiotics. During his 12-day hospitalization, Mike received countless injections in his stomach and endured agonizing pain. For the next two months, Mike made multiple trips to the hospital and faced an uncertain prognosis. In August, he learned that 14 other people had suffered similar injuries after receiving calcium gluconate injections from Specialty Compounding, LLC.

After reports of bacterial bloodstream infections affecting 15 patients at two Texas hospitals (Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area) circulated, Specialty Compounding issued a voluntary recall on August 9, 2013. On August 14, the CDC issued a health advisory on the recall that confirmed the deaths of two patients who received infusions of Specialty Compounding’s Calcium Gluconate 2 grams in Sodium Chloride 0.9 percent for Injection. The Texas Department of State Health Services reported that most of the bacterial bloodstream infections were caused by Rhodococcus equi, a bacterium known to infect pigs, goats, horses, sheep, cattle, and humans. Furthermore, Texas health officials announced that cultures from an intact sample of Specialty Compounding’s calcium gluconate revealed bacterial growth consistent with the Rhodococcus organism. On August 15, Specialty Compounding expanded its recall to include all unexpired sterile productsincluding all strengths and dosage forms.

Although Specialty Compounding issued a press release claiming that no calcium gluconate was shipped outside of Texas, the Cedar Park-based pharmacy confirmed that it distributed its other recalled products for sterile use nationwide with the exception of North Carolina. This recall follows a March inspection by the FDA of Specialty Compounding’s facilities in which investigators identified sterility concerns over multiple drugs, including calcium gluconate. The FDA observed that “[p]rocedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.” Further, investigators reported that Specialty Compounding “does not conduct routine sterility or endotoxin testing for all injectable drugs currently produced.” The FDA identified problematic safety control practices regarding the following drugs:

  • Acetylcysteine 20% (using powder) 200mg/mL Inhalation Solution
  • Bupivicane Hydrochloride (Preservative-Free) 0.75% Injectable
  • Calcium Gluconate 10% (100mg/mL) Injectable
  • Cefazolin 2gm in 100mL Sodium Chloride 0.9% Injectable
  • DMPS (Dimercaptopropanesulfonic Acid) Preservative-Free 5% Injectable
  • Ephedrine Sulfate (Preservative-Free) 50mg/mL Injectable
  • Fentanyl (NICU Syringe) 10mcg/mL Injectable
  • Fentanyl (Preservative-Free) 50mcg/mL
  • Furosemide 10mg/mL Injectable
  • Glutathione/Adenosine Triphosphate 100mg/1mg/mL Injectable
  • Hydrogen Peroxide (Preservative-Free) 3.75% Injectable
  • Hydromorphone (Preservative-Free) Stock Injection 50mg/mL
  • Magnesium Sulfate 2gm/100mL Sodium Chloride 0.9% for Injection
  • Methylcobalamin (Preservative-Free) 12.5mg/mL Injectable
  • Methylcobalamin/Folic Acid (Preservative-Free) 1mg/10mg/mL Injectable
  • Morphine Sulfate (Preservative-Free) 0.5mg/mL Injectable
  • Sodium Phenylbutyrate 200mg/mL Injectable

We encourage consumers and loved ones who have been affected by Specialty Compounding’s “sterile” medications and those interested in learning more about the tragic outbreak to visit the Specialty Compounding Bacterial Infection Victims Support Page on Facebook. For a free case evaluation, contact us at www.andrewsthornton.com or toll free at 1-800-644-1734.

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